Viewpoint 2:A scientific approach to link effective care measurement

with tangible improvement

Professor Mike GrocottProfessor of Anaesthesia and Critical Care Medicine.

Chair, National Emergency Laparotomy AuditDirector of the NIAA Health Services Research Centre,

Health Services Research Centre RCoA

Declaration of interests

• I am a co-investigator on the EPOCH study

Linking audit to quality improvement?

• Definitions

• Healthcare problem = emergency laparotomy

• HQIP Audit = NELA

• Adding value through linked research projects

• Conclusions

Definitions and context

• Clinical audit• ”…a quality improvement process that seeks to

improve patient care and outcomes through systematic review of care against explicit criteria and the implementation of change.”

NICE 2002

Definitions and context

• Emergency Laparotomy• An abdominal surgical procedure performed at

short notice to treat life-threatening intra-abdominal conditions e.g. obstruction or perforation of the bowel

Definitions and context

• ELN = Emergency Laparotomy Network

• NELA = National Emergency Laparotomy Audit

• EPOCH = Enhanced Perioperative Care for High-Risk Patients (clinical trial)

Emergency Laparotomy: 1998-2012

• High incidence of adverse outcome

• Poor supervision

• Low critical care usage

• High cost

Cook BJA 1998Ford BJA 2007

Shapter Anaesthesia 2012

Emergency Laparotomy: 1998-2012

Symons BJS 20132000-2009n = 367,796

Emergency Laparotomy Network (ELN)

Emergency Laparotomy Network (ELN)

Saunders BJA 2012

ELN results: data collection

• 37 Hospitals returned data• 2 hospitals excluded (< 50% case ascertainment)

• 35 hospitals • > 90% case ascertainment• 1853 patients• 1941 emergency laparotomies• 46 (range 8-184) procedures per hospital

Saunders BJA 2012

ELN results: outcomes

Saunders BJA 2012

<20 21-30

31-40

41-50

51-60

61-70

71-80

81-90

91-100

0

5

10

15

20

25

30

35

Proportion %Mortality %

Age (years)

%

ELN results: outcomes

Saunders BJA 2012

<20 21-30

31-40

41-50

51-60

61-70

71-80

81-90

91-100

0

5

10

15

20

25

30

35

Proportion %Mortality %

Age (years)

%

ELN results: outcomes

ASA - Physical Status Classification

Number Mortality (%)

1 113 0

2 565 4.1

3 643 13.4

4 332 33.6

5 42 69.2

Saunders BJA 2012ASA = American Society of Anesthesiologists

ELN results: outcomes

Saunders BJA 2012

ELN results: process measures

• Consultant Surgeon present (41-100%)• Consultant Anaesthetist present (25-100%)• Level 3 care (10-88%)• Goal-directed fluid therapy (0-63%)

• Consultant presence decreases out of hours

Saunders BJA 2012

NELA: overview

• 2012-13 Organisational audit

• 2013-2015 Individual patient audit

• Wide range of stakeholders (CRG)

• Web-based data entry (and feedback)

NELA: organisational audit

• December 2012-13

• 190/191 eligible hospitals

• Report published May 2014

NELA: organisational audit

• Consultant availability variable

• 1/5 no dedicated theatre

• 2/3 no interventional radiology

• 2/3 no endoscopy

• Pathways and audit variable

NELA: patient audit

• 191/191 entering patient-level data

• First 6 months results reflect ELN data12345678

Cases Entered

NaN

1136

2633

4652

6302

8171

10283

12522

target (60% total)

100030005000

Case Completion Rates

NELA: quality improvement

• Organisational audit• Model action plan• Sharing best practice

• Patient audit• Local availability of data• Software added value e.g. run charts

How does audit achieve QI?

How does audit achieve QI?

• Effect of data collection “Hawthorne effect”

• Audit driving QI

Ivers Cochrane DSR 2012

How does audit achieve QI?

• Effect of data collection “Hawthorne effect”

• Audit driving QI

• Research studies• Observational studies• Platform for interventional studies

Ivers Cochrane DSR 2012

Audit and QI

• Observational vs. interventional studies• Confounding• Bias

Anglemyer Cochrane DSR 2014

Enhanced Peri-Operative Care

for High-risk patients

EPOCH

Chief Investigator: Prof Rupert PearseQI Lead: Prof Carol Peden

EPOCH background: emergency laparotomy

• Emergency Laparotomy Network & HES data

• ≈ 30,000 cases per year (England and Wales)

• Overall 25% mortality at 90 days

• Variation in 30-day mortality (4 to 31%)

• Variation in delivered care (vs. standards)

EPOCH background: enhanced recovery

Enhanced Recovery Partnership DoH 2012

Mean length of stay

Day of surgery

admission

EPOCH: objectives

• Can a quality improvement project to implement a care pathway improve 90-day survival for emergency laparotomy?• Integrated ethnographic evaluation• Cost-effectiveness of project• Long-term impact on mortality (via HQIP-NELA)

EPOCH: trial design

• Stepped wedge randomised cluster trial

• Data capture via HQIP-NELA web portal

• Intervention (vs. usual care):• Integrated Care Pathway• Based on RCS-DoH Recommendations• Package of training and support

RCTs and Cluster RCTs

• RCT = randomised controlled trial• Minimisation of confounding (randomisation)• Minimisation of bias (blinding)• A priori analysis plan addressing single question

• RCT: unit of randomisation = patient• Cluster RCT: unit of randomisation = cluster

Parallel Group Cluster RCT

Brown BMC Med Res Meth 2006

RANDOMISE

CONTROL

INTERVENTION

Stepped Wedge Cluster RCT

Brown BMC Med Res Meth 2006

EPOCH: trial timelines

• December 2013 • Start-up

• March 2014• Trial starts

• April 2014• First cluster ‘activated’

• August 2015 • Final cluster activated

• Mid - Sept 2015• Final patient recruited

EPOCH: patients

• Aged ≥40 years undergoing non-elective open abdominal surgery in acute NHS hospitals

• Exclusions: Gynaecological and trauma laparotomy, Repeat laparotomy, Appendicectomy

EPOCH: integrated care pathway

• Visits by QI experts

• Local champions

• Local & cluster level multidisciplinary meetings

• Web resources

• Local review of local data

EPOCH: integrated care pathway

• Visits by QI experts

• Local champions

• Local & cluster level multidisciplinary meetings

• Web resources

• Local review of local data

Comparator = usual care

EPOCH: outcome measures

• Primary: 90 day mortality

• Secondary:• Hospital stay• Hospital re-admission• 180 day mortality• Cost effectiveness

EPOCH: sample size

• 98 NHS hospitals in 15 regional clusters

• 27,540 patients

• 90% power: 25 to 22% mortality reduction

• Fixed 85 week intervention period

• Potential to recruit every eligible patient

NELA-EPOCH: learning points

• Risk of confusion over aims of distinct projects

• Risk of internal conflicts of interest/roles

• Risk of brand confusion and disengagement

• EPOCH will distort the results of NELA

• NELA will distort the results of EPOCH

NELA-EPOCH: learning points

• QI agenda gives the audit more “meaning”

• EPOCH evaluates QI that NELA may role out

• Parallel publicity promotes the shared agenda

• Collaborative team working helps both projects

• Importance of clearly defined roles

Would we do it again?

• Yes

• Yes

• Yes

• Better wait for the results!

Linking audit to quality improvement?

• Audit alone can improve quality

• Audit plus focussed QI offers greater improvement

• National audits offer an economical and efficient platform for clinical trials

• Research informs standards and guidelines

• The combination may increase the rate of quality improvement derived from national audits

Linking audit to quality improvement?

Any questions…?